Sensors, interfaces and sensor systems for data collection and integrated remote monitoring of conditions at or near body surfaces

ABSTRACT

Sensing devices including flexible and stretchable fabric-based pressure sensors may be associated with or incorporated in garments intended to be worn against a body surface (directly or indirectly), or may be associated with other types of flexible substrates, such as sheet-like materials, bandages, and other materials that contact the body (directly or indirectly), and may be provided as independently positionable sensor components. Systems and methods for storing, communicating, processing, analyzing and displaying data collected by sensor components for remote monitoring of conditions at body surfaces, or within the body, are also disclosed. Sensors and sensor systems provide substantially real-time feedback relating to current body conditions and may provide notifications or alerts to users, caretakers, and/or clinicians, enabling early intervention when conditions indicate intervention is appropriate.

REFERENCE TO RELATED PATENT APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 13/753,456, filed Jan. 29, 2013, which claims priority fromU.S. Provisional Patent Application No. 61/592,333, filed Jan. 30, 2012and from U.S. Provisional Patent Application No. 61/747,877 filed Dec.31, 2012. The disclosures of the previous applications are incorporatedby reference herein in their entireties.

FIELD

The present invention relates generally to sensors, including flexibleand stretchable fabric-based pressure sensors, that may be associatedwith or incorporated in garments intended to be worn against a bodysurface (directly or indirectly). Sensors may also be associated with orincorporated in sheet-like materials, bandages and other accessoriesthat contact the body (directly or indirectly), and may be provided asindependently positionable sensor components. Systems and methods forstoring, communicating, processing, analyzing and displaying datacollected by sensor components for remote monitoring of conditions atbody surfaces, or within the body, are also disclosed. Sensors andsensor systems provide substantially real-time feedback relating tocurrent body conditions and may provide notifications or alerts tousers, caretakers and/or clinicians, enabling early intervention whenconditions indicate intervention is appropriate.

BACKGROUND

Various types of sensing systems have been incorporated in shoes,insoles, socks and garments for monitoring various physiologicalparameters for various applications, including recreational, sporting,military, diagnostic and medical applications. Medical applications forsensing pressure, temperature and the like for purposes of monitoringneuropathic and other degenerative conditions with the goal of alertingindividual and/or medical service providers to sensed parameters thatmay indicate the worsening of a condition, lack of healing, and thelike, have been proposed. Footwear-related sensing systems directed toproviding sensory data for patients suffering from neuropathy, for gaitanalysis, rehabilitation assessment, shoe research, design and fitting,orthotic design and fitting, and the like, have been proposed.

Potential causes of peripheral neuropathy include diabetes, alcoholism,uremia, AIDS, tissue injury and nutritional deficiencies. Peripheralneuropathy is one of the most common complications of diabetes andresults in wounds, ulcers, etc., which may be undetected and unsensed bythe individual. There are 25 million diabetics in the US alone, with aprojected population of 500 million diabetics worldwide by 2030. In thepresence of neuropathy, diabetic patients often develop ulcers on thesole of the foot in areas of moderate or high pressure and shear, oftenresulting from walking during normal daily activities. About 70% ofdiabetics have measurable neuropathy, and every year about 5% of thosepatients get foot ulcers, and about 1% requires amputations. Foot ulcersare responsible for more hospitalizations than any other complication ofdiabetes and result in at least $40 billion in direct costs annually.

There is strong evidence that uncomplicated plantar ulcers can be healedin 6-8 weeks, yet current US clinical trials have reported a 76%treatment failure rate at 12 weeks. Many approaches to monitoringdiabetic patients for the purpose of preventing ulceration fromoccurring, or to facilitate healing of existing ulcers, have beenproposed, yet little or no improvement in ulceration or itscomplications has been observed. Off-loading may be an important aspectof ulcer prevention and healing. In “Practical guidelines on themanagement and prevention of the diabetic foot,” the authors concludedthat mechanical off-loading is the cornerstone of treatment for ulcerswith increased biomechanical stress. See, Diabetes Metab. Res. Rev.2008; 24 (Suppl 1): S181-S187. It has been demonstrated that theoffloading capacity of custom-made footwear for high-risk patients canbe effectively improved and preserved using in-shoe plantar pressureanalysis as guidance for footwear modification, which should reduce therisk of pressure-related diabetic foot ulcers. See, e.g., Diabet. Med.2012 December;29 (12):1542-9. Sensing devices and footwear havingsensors incorporated for monitoring pressure and other body parametershave been proposed. These devices have generally not been successful inpreventing ulceration or accelerating healing of wounds, in part as aresult of poor patient compliance. Notwithstanding the existence ofseveral pressure sensing systems, the incidence of, patient pain andcosts associated with diabetic ulcers has not declined. In one aspect,the components and assemblies for collection and analysis of data fromsites such as feet and other body surfaces described herein are directedto providing intermittent or continuous monitoring and reporting of bodyconditions (such as pressure) at body locations for purposes of reducingthe incidence and severity of ulcers and other wounds and acceleratingthe pace and quality of wound healing. In other aspects, sensors,interfaces, systems and materials described herein for collection andanalysis of physiological and biomechanical data from sites such as feetand other body parts may be used for a variety of sports-related,military, fitness, diagnostic and therapeutic purposes.

SUMMARY

In one aspect, sensor systems of the present invention comprise one ormore sensor(s) mounted to or incorporated in or associated with asubstrate material such as a wearable garment, a wearable band, anindependently positionable component, or another substrate, such as aflexible and/or pliable sheet material. In one aspect, sensors arecapable of sensing a physiological parameter of the underlying skin ortissue, or sensors are capable of sensing force or pressure exerted onor against an underlying skin or tissue. Each sensor is electricallyconnected, via one or more flexible leads, to a flexible conductivetrace mounted to or incorporated in or associated with the substrate,and conductive traces terminate at conductive signal transfer terminalsmounted to or incorporated in or associated with the substrate. Sensorsystems and sensing devices described herein preferably comprise atleast one flexible sensor (or means for sensing), and one or more of thesensor(s), flexible leads, and conductive traces may be stretchableand/or elastic as well as being flexible. In some embodiments, thesensor(s), flexible leads and conductive traces may all compriseflexible, pliable electrically conductive fabric materials. Garmentsincorporating such sensor systems and sensing devices may be comfortablyworn by users under many conditions, providing real time monitoring ofconditions at or near body surfaces to the user, a caretaker, and/orclinician.

The signal transfer terminal(s) on the substrate may be matinglyreceived in signal receipt terminals associated with a DedicatedElectronic Device (DED) that is attachable to the substrate and servesas a (temporary or permanent) data collection device. The DED may also(optionally) house batteries or other energy storage devices and serveas a sensor charging device. The DED communicates with one or moreexternal electronic device(s), such as a smartphone, personal computingdevice/display, host computer, or the like for signal transfer,processing, analysis and display to a user and/or others. In someembodiments, the external electronic device, and/or the DED,communicates with an external, hosted computing system (operated, e.g.,at a centralized, hosted facility and/or in the “Cloud”) that providesadditional data analysis, formulates feedback, notifications, alerts,and the like, that may be displayed to the user, a caretaker, and/or aclinician through one or more computing and/or display devices.

In some embodiments, one or more sensor(s) detect changes in voltage orresistance across a surface area that is associated with force exertedon the sensor, which is related to pressure (as force per unit surfacearea) and/or shear. In some embodiments, FSR (Force Sensitive Resistor)or piezo-resistive sensors may be used. One type of piezoresistive forcesensor that has been used previously in footwear pressure sensingapplications, known as the FLEXIFORCE® sensors, can be made in a varietyof shapes and sizes, and measure resistance, which is inverselyproportional to applied force. These sensors use pressure sensitive inkswith silver leads terminating in pins, with the pressure sensitive areaand leads sandwiched between polyester film layers. FLEXIFORCE® sensorsare available from Tekscan, Inc., 307 West First Street, South Boston,Mass. 02127-1309 USA. Other types of sensors may also be integrated inor associated with various substrate materials (e.g., garments, sheetmaterials and the like), including sensors providing data relating totemperature, moisture, humidity, stress, strain, heart rate, respiratoryrate, blood pressure, blood oxygen saturation, blood flow, local gascontent, bacterial content, multi-axis acceleration, positioning (GPS)and the like. A variety of such sensors are known in the art and may beadapted for use in sensing systems described herein.

In some embodiments, pressure sensors and/or associated leads and/orconductive traces incorporated in sensing systems of the presentinvention comprise non-silicon-based materials such as flexible,conductive “e-textile” fabric material(s). In some embodiments, sensorsand/or associated leads and/or conductive traces incorporated in sensingsystems of the present invention comprise flexible, conductive fabricmaterials that are substantially isotropic with respect to theirflexibility and/or stretch properties. By “substantially” isotropic, wemean to include materials that have no more than a 15% variation and, insome embodiments, no more than a 10% variation in flexibility and/orstretch properties in any direction, or along any axis of the material.Suitable materials, such as piezoresistive fabric sensors, coated and/orimpregnated fabrics, such as metallic coated fabric materials and fabricmaterials coated or impregnated with other types of conductiveformulations, are known in the art and a variety of such fabric sensorsmay be used. In some embodiments, pressure sensors comprise flexibleconductive woven fabric material that is stretchable and/or elasticand/or substantially isotropic with respect to their flexibility and/orstretch properties.

Fabrics comprising a knitted nylon/spandex substrate coated with aconductive formulation are suitable for use, for example, in fabricatingbiometric pressure sensors and in other applications requiringenvironmental stability and conformability to irregular configurations.One advantage of using these types of e-textile sensors is that theyperform reliably in a wide variety of environments (e.g. under differenttemperature and moisture conditions), and they're generally flexible,durable, washable, and comfortably worn against the skin. Suitableflexible conductive fabric materials are available, for example, fromVTT/Shieldex Trading USA, 4502 Rt-31, Palmyra, N.Y. 14522, from StatexProductions & Vertriebs GmbH, Kleiner Ort 11 28357 Bremen Germany, andfrom Eeonyx Corp., 750 Belmont Way, Pinole, Calif. 94564.

Techniques for deriving force and/or pressure measurements usinge-textile fabric materials are known in the art and various techniquesmay be suitable. See, e.g., http://www.kobakant.at/DIY/?p=913.Techniques for measuring other parameters using e-textile fabricmaterials, such as humidity and temperature measurements, are also knownand may be used in sensing systems of the present invention. See, e.g.,http://www.nano-tera.ch/pdf!posters2012/TWIGS105.pdf. Fabric sensors ofthe present invention may thus be capable of monitoring variousparameters, including force, pressure, humidity, temperature, gascontent, and the like, at the site. Additional monitoring capabilitiesmay be available using fabric sensors as innovation in fabric sensorsproceeds and as nano-materials and materials incorporatingnano-structures are developed and become commercially feasible. Flexible(and optionally stretchable or elastic) conductive fabric sensor(s),leads and/or traces may be mounted to/in/on, or associated with, anunderlying substrate such as fabric or sheet material that'snon-conductive and flexible. The term “fabric” or “sheet material” asused herein, refers to many types of pliable materials, includingtraditional fabrics comprising woven or non-woven fibers or strands, aswell as fiber reinforced sheet materials, and other types of flexiblesheeting materials composed of natural and/or synthetic materials,including flexible plastic sheeting material, pliable thermoplastic,foam and composite materials, screen-like or mesh materials, and thelike. The underlying substrate may comprise a sheet material fabricatedfrom flexible fabric material that is stretchy and/or elastic. The sheetmaterial forming the underlying substrate may be substantially isotropicwith respect to its flexibility and/or stretch properties. By“substantially” isotropic, we mean to include materials that have nomore than a 15% variation and, in some embodiments, no more than a 10%variation in flexibility and/or stretch properties in any direction, oralong any axis of the material.

For garment applications, for example, one or more sensor(s) and/orsensing devices may be mounted to (e.g., sewn or otherwise attached orconnected or fixed to) an internal surface of a garment for contactingan individual's skin, directly or indirectly, during use, and detectingpressure exerted against an individual's skin, or other parameterssensed at or near a skin surface. In situations where pressure or otherparameters are desired to be measured as they impact an outer surface orfabric layer, one or more sensor(s) may be mounted (e.g., sewn orotherwise attached or connected or fixed to) an external surface of agarment. For applications such as bands, bandages and independentlypositionable sensing components, sensors may likewise be mountedto/in/on, or associated with (e.g., sewn or otherwise attached orconnected to or fixed to) an underlying substrate that may beconveniently positioned as desired by the user, a caretaker orclinician. In alternative embodiments, conductive yarns and/or e-textilefabric sensors may be knitted into, sandwiched between substrate layers(as in compression socks) or otherwise incorporated in fabricsubstrates.

In some embodiments, conductive fabric sensors may be partially or fullyenclosed in a flexible barrier material or envelope. Conductive fabricsemployed for the sensors, leads and/or traces are generally waterresistant and water resistant fabrics are suitably used, without the useof a barrier, for many applications. In cases where the sensor isfrequently exposed to body fluids, natural liquids or other solutions(e.g., water, sweat, other bodily fluids) however, the e-properties(e.g., electrical conductivity) of the material can be negativelyaffected by fluid contact and build-up of biological or other debris. Tomitigate this condition, a substantially liquid impervious barrier maybe provided to protect the sensor(s), leads and/or traces from directcontact with liquids or other materials. In some embodiments, a sandwichapproach in which a conductive sensor is enclosed in a substantiallyliquid impervious barrier may be employed to protect the sensor fromcontact with liquids and preserve the core resistive features(e-properties) and functions of the sensor(s). Providing a protectivebarrier covering and/or enclosing the sensor(s) may also be particularlyuseful in cases when the sensor(s) cannot be exposed directly to an openwound or to a particularly sensitive area of human skin. The barrier maybe placed to seal the sensor(s) alone, or the leads and/or traces may besealed as well. When protected sensing components are used, externalsurface(s) of the barrier layer(s) may be attached to the underlyingsubstrate (e.g., garment, skin or the like) via adhesive materials or inother ways.

Each sensor is generally associated with two conductive leads, and eachof the leads is electrically connected to a conductive trace conveyingelectrical signals to a signal transfer terminal. Conductive e-textilefabric sensors as previously described may be electrically connected toconductive leads, or may have a flexible fabric lead associated with orincorporated in the fabric sensor footprint. In general, flexible,conductive e-textile leads may comprise conductive fabric materialshaving high electrical conductivity. Other types of flexible leads,including conductive yarns, fibers, and the like may also be used. Theconductive leads are electrically connected to flexible conductivetraces, which may comprise a variety of flexible conductive materials,such as a conductive fabric, conductive yarn, or the like. In someembodiments, the conductive traces are stretchable and/or elastic, atleast along the longitudinal axis of the conductive trace. In someembodiments, conductive traces comprise a conductive e-textile fabrichaving high electrical conductivity, such as silver coated e-textilematerials, and may be bonded to the underlying substrate material usingadhesives, heat bonding or non conductive threads. Suitable e-textilematerials are known in the art and are available, for example, from thevendors identified above.

Sensor(s) as described herein and sensor systems, including fabrice-textile pressure sensors and a variety of other types of sensors, withconductive leads and traces, may be associated with a variety ofsubstrates including, without limitation, garments intended to be worn(directly or indirectly) against the skin of an individual, such as ashirt or tunic, underwear, leggings, socks, footies, gloves, caps, bandssuch as wrist bands, leg bands, torso and back bands, brassieres, andthe like. Sensors and sensor systems may additionally be associated withwraps having different sizes and configurations for fitting onto orwrapping around a portion of an individual's body, and with bands,bandages, wound dressing materials, as well as with other types ofaccessories that contact a user's body surface (directly or indirectly)such as insoles, shoes, boots, belts, straps, and the like. Conductiveleads associated with each sensor are electrically connected toconductive traces, as described, which terminate at signal transferterminals associated with the underlying substrate garment, band, wrap,bandage, or the like.

Each of the conductive traces terminates in a signal transfer terminalthat is mounted to/in/on, or associated with, the underlying substrateand can be associated with a mating signal receipt terminal of adedicated electronic device (DED) having data storage, processing and/oranalysis capabilities. In general, conductive traces and terminals arearranged in a predetermined arrangement that corresponds to thearrangement of signal receipt terminals in the DED. Many different typesof signal transfer and receipt terminals are known and may be used inthis application. In one exemplary embodiment, signal transfer andreceipt terminals may be mounted in cooperating fixtures for slidingengagement of the terminals. In another embodiment, signal transferterminals may be provided as conductive fixtures that are electricallyconnected to the conductive trace (and thereby to a correspondingsensor) and detachably connectible to a mating conductive fixturelocated on the DED. The mating terminals may comprise mechanicallymating, electrically conductive members such as snaps or other types offasteners providing secure mechanical mating and high integrity, highreliability transfer of signals and/or data. In some embodiments, easyand secure mating of the terminals may be enhanced using magneticmechanisms or other types of mechanisms that help users to properlyconnect/disconnect the mating terminals with minimal effort. Forexample, the mechanism may allow an overweight diabetic patient to reachdown to his own legs or feet and easily snap or unsnap the DED to/fromthe wearable device without excessive effort.

The DED, in addition to having data recording, processing and/oranalysis capabilities, may incorporate an energy source such as abattery providing energy for data recording, processing and/or analysis,as well as providing energy for operation of one or more of thesensor(s). The energy source is preferably a rechargeable and/orreplaceable battery source. The DED generally provides a lightweight andwater-tight enclosure for the data collection and processing electronicsand (optional) energy source and provides receiving terminals that matewith the transfer terminals connected to the sensor(s) for conveyingdata from the sensors to the dedicated electronic device.

Dedicated electronic devices having signal receipt terminals that matewith the signal transfer terminals associated with the substrate maytake a variety of form factors, depending on the form factor of theunderlying sensing substrate and/or the conditions and location of thedevice during use. When sensors are incorporated in a sock-like formfactor for monitoring conditions sensed at the foot, for example, thesignal transfer terminals may be arranged in proximity to one another inan ankle region of the sock, and the DED may have the curved form factorof a band that extends partially around the ankle or lower leg andattaches to the underlying signal transfer terminals and sock substratealong a front and/or side portion of the user's ankle or lower leg. Whensensors are incorporated in a wrap or band, the signal transferterminals may be arranged at or near an exposed end of the wrap or bandfollowing its application to an underlying anatomical structure or bodysurface, and the DED may be provided as a band or a tab or a dongle-likeor capsule-like device having aligned signal receipt terminals. The DEDmay be provided as a substantially flexible or a substantially rigidcomponent, depending upon the application, and it may take a variety offorms.

The DED preferably communicates with and transfers data to one or moreexternal computing and/or display system(s), such as a smartphone,computer, tablet computer, dedicated computing device, medical recordssystem or the like, using wired and/or wireless data communication meansand protocols. The DED and/or an external computing and/or displaysystem may, in turn, communicate with a centralized host computingsystem (located, e.g., in the Cloud), where further data processing andanalysis takes place. Substantially real-time feedback, including datadisplays, notifications, alerts and the like, may be provided to theuser, caretaker and/or clinician according to user, caretaker and/orclinician preferences.

In some embodiments, the DED may store the data temporarily to a localmemory, and periodically transfer the data (e.g., in batches) to theabove mentioned external computing and/or display system(s). Offlineprocessing and feedback, including data displays, notifications and thelike may be provided to the user, caretaker, and/or clinician accordingto user, caretaker and/or clinician preferences.

In operation, an authentication routine and/or user identificationsystem matches the DED and associated sensing system (e.g., thecollection of sensor(s) associated with an underlying substrate) withthe user, caretaker and/or clinician, and may link user information ordata from other sources to a software- and/or firmware-implementedsystem residing on the external computing system. The external computingdevice may itself communicate with a centralized host computing systemor facility where data is stored, processed, analyzed, and the like, andwhere output, communications, instructions, commands, and the like maybe formulated for delivery back to the user, caretaker and/or clinicianthrough the external computing device and/or the DED.

Calibration routines may be provided to ensure that the DED andconnected related sensor system are properly configured to workoptimally for the specific user. Configuration and setup routines may beprovided to guide the user (or caretaker or medical professional) toinput user information or data to facilitate data collection, andvarious protocols, routines, data analysis and/or displaycharacteristics, and the like, may be selected by the user (or caretakeror medical professional) to provide data collection and analysis that istargeted to specific users. Specific examples are provided below.Notification and alarm systems may be provided, and selectively enabled,to provide messages, warnings, alarms, and the like to the user, and/orto caretakers and/or medical providers, substantially in real-time,based on sensed data.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an exemplary sensing device having a sock form factor andhaving one or more sensor patches electrically connected to one or moreterminals by means of conductive pathways.

FIG. 2 shows another exemplary sensing device similar to that shown inFIG. 1 and having a different arrangement of sensor patches electricallyconnected to terminals by means of conductive pathways.

FIG. 3 shows another view of an exemplary sensing device similar to thatshown in FIGS. 1 and 2.

FIG. 4 shows a view of terminals of the sensing device and an explodedview of a detachable dedicated electronic device that, when attached toterminals on the sock, captures and optionally processes, stores and/oranalyzes sensed signals or data.

FIG. 5 shows an enlarged, exploded view of an exemplary detachableelectronic device similar to that shown in FIG. 4.

FIGS. 6A and 6B show schematic illustrations of exemplary sensors havingleads provided in different configurations.

FIG. 7 shows an image illustrating a sensor of the type illustrated inFIG. 6A mounted on a fabric substrate, with each of the leads connectedto a conductive trace.

FIG. 8 shows an image illustrating two exemplary conductive tracesmounted on an internal surface of a fabric substrate in a sock-like formfactor, terminating in conductive signal transmit terminals thatpenetrate the fabric substrate.

FIG. 9 shows an image illustrating two exemplary sensors of the typeillustrated in FIG. 6A mounted on a fabric substrate, with each of theleads connected to a conductive trace and each of the traces terminatingin a conductive signal transmit terminal.

FIG. 10 shows an image illustrating the external surface of a fabricsubstrate in a sock-like form factor, showing multiple conductiveterminals for mating with terminals of an intermediate device.

FIGS. 11A and 11B show images illustrating dedicated electroniccomponent for connecting to signal transmit terminals having a curvedform factor for mounting at an ankle or lower leg portion of a user.

FIGS. 12A and 12B show a schematic diagrams illustrating one embodimentof mating mechanical and magnetic fasteners providing a mechanical andelectrical connection between the dedicated electronic component and thesignal transmit terminals, via mating magnetic snaps. FIG. 12A shows aschematic exploded diagram illustrating exemplary components of the maleconnector; FIG. 12B shows a schematic exploded diagram illustratingexemplary components of the female connector.

FIG. 13 shows an image illustrating a sensor-activated device of thetype shown in FIGS. 7-10 having a sock-like form factor in place on auser's foot, with an intermediate device having an anklet-like formfactor as shown in FIGS. 11A and 11B connected to the external terminalsfor data collection and, optionally, analysis.

FIG. 14 shows a block diagram illustrating basic components of anexemplary data collection device and illustrating its interface withsensors provided in a substrate, an external computing device, and acentralized host system maintained, for example, in the Cloud.

FIG. 15 shows an image illustrating an independently positionable sensormounted to conductive leads and signal transmit terminals for placementat the discretion of a patient or care provider.

FIG. 16A illustrates the placement of an independently positionablesensor device of the type illustrated in FIG. 15 at a location (e.g., onthe bottom of a patient's foot or between layers of bandages) where thepatient and/or caretaker would like to monitor conditions (e.g.,pressure and/or shear), and FIG. 16B illustrates signal transferterminals connected to conductive traces connected to the sensor thatare positionable, for example at the top of a patient's foot or on theexterior of a bandage, for connection to a dedicated electroniccomponent.

FIG. 17 shows an image illustrating one view of a sensing system using asensor device as illustrated in FIGS. 15-16B in combination with aversatile wrap, with the conductive signal transfer terminals exposedfor connection to an electronic intermediate such as a DedicatedElectronic Device (DED).

FIGS. 18A and 18B illustrate an exemplary textile sensor employing aprotective, substantially liquid impermeable barrier. FIG. 18A shows oneface of the assembled sensor system and FIG. 18B shows the opposite faceof the assembled sensor system.

FIG. 19 schematically illustrates a sensing system having one or moresensors with leads and conductive traces terminating in terminals in abandage or wrap form factor.

FIG. 20 schematically illustrates a fabric-based sensing system havingmultiple sensors with leads and conductive traces terminating in signaltransmit terminals for connection to an intermediate electronic devicefor data collection, storage and/or processing.

FIG. 21 schematically illustrates a patient setup protocol, cliniciandashboard and patient offloading data display for monitoring wounds suchas foot ulcers.

FIGS. 22A-22L illustrate exemplary device set ups, calibration andmonitoring criteria input and routines, along with an exemplaryclinician dashboard, a graphical representation of patient offloadingdata, and an exemplary sample of acquired pressure data. FIG. 22A showsexemplary setup and calibration steps; FIG. 22B shows an exemplarypatient data input routine; FIG. 22C shows an exemplary device setuproutine; FIG. 22D shows an exemplary device setup routine; FIG. 22Eshows another exemplary device setup routine; FIG. 22F shows anotherexemplary device setup routine; FIG. 22G shows an exemplary monitoringroutine setup; FIG. 22H shows another exemplary monitoring routinesetup; FIG. 22I shows an exemplary user calibration routine; FIG. 22Jshows an exemplary clinician dashboard presenting patient statusinformation for a plurality of patients using a sensing device of thepresent invention; FIG. 22K shows an exemplary patient offloading datadisplay; and FIG. 22L shows exemplary pressure data collected using anexemplary sensing system of the present invention.

FIG. 23 shows an exemplary sensing system having sensors located in asock, with one or more sensors electrically connected to one or moreterminals, and subsequently to a dedicated electronic device located ina shin guard. It will be understood that the appended drawings are notnecessarily to scale, and that they present simplified, schematic viewsof many aspects of systems and components of the present invention.Specific design features, including dimensions, orientations, locationsand configurations of various illustrated components may be modified,for example, for use in various intended applications and environments.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS Sensors and Sensor SystemsUsed in a Sock-like Form Factor

In one embodiment, systems incorporating sensors, leads, traces andterminals may be mounted to and/or incorporated in or associated with agarment having a sock-like form factor. One version of this embodimentis illustrated in FIGS. 1-5. In general, a substrate material in theform of a sock may be equipped with one or more sensors, leads, tracesand connectors that provide signals and/or data to a dedicated (andpreferably detachable) electronic device that gathers data from eachsensor and communicates to an external computer and/or mobile device.Sensors used in footwear and sock applications typically includepressure sensors capable of detecting levels of pressure (and/or forceand/or shear) at one or more areas of the foot and may include othertypes of sensors, including temperature, accelerometers, heart ratemonitors and/or moisture sensors, and the like. Based on the detectedpressure, force and/or shear at one or more areas of the foot, andtrends in those parameters over one or more monitoring period(s),conclusions relating to the lack of proper offloading and relatedconditions of the underlying skin or tissue, healing progression (orlack of healing), discomfort, extent and seriousness of injury, and thelike, may be drawn and may be communicated to the user, caretaker and/orclinician, essentially in real time. In addition, notifications, alerts,recommended actions, and the like may also be communicated to the user,caretaker and/or clinician based on the data analysis, essentially inreal time. These systems are suitable for use in medical and patientadherence monitoring applications, diabetic (and other) foot monitoring,sports and fitness applications, footwear fitting applications, militaryapplications, etc.

One embodiment of a sensor system embodied in a sock-like form factor isillustrated in FIGS. 1-5. In this embodiment, a flexible and preferablystretchable fabric substrate in the form of a sock 1 has one or moresensors, shown as sensor patches 2, optionally including one or morepressure sensors constructed from flexible and conductive fabric asdisclosed herein. Each of the sensor patches 2 has leads and conductivetraces or threads 3, each terminating in a conductive signal transferterminal 4. The sensor patches 2 and conductive traces or threads 3 maybe woven into the fabric forming the sock, or may be applied to asurface of the fabric forming the sock. In one embodiment, e-textilefabric pressure sensors are applied to an internal surface of the fabricthat contacts a user's skin (directly or indirectly) when the sock isworn. Additional fabric sensors may be used in connection with the sock,and other types of sensors, including heat sensors (e.g.,thermocouples), moisture sensors, and the like, may also be incorporatedin the sock with leads and traces terminating in additional signaltransfer terminals. In general, the conductive traces may be applied toan internal or external surface of the underlying fabric substrate, andthe terminals preferably have a conductive transfer interface accessibleto the external surface of the fabric substrate. In the embodimentillustrated in FIGS. 1-5, the signal transfer terminals 4 are positionedin proximity to the top of the sock, although it will be appreciatedthey may be positioned elsewhere.

The signal transfer terminals 4 that connect to the sensor(s) in thesock are connectible to mating signal receiving terminals of adetachable electronic device (DED). Simplified diagrams illustratingexemplary DEDs are shown in FIGS. 4 and 5. Detachable electronic device5 receives signals from each of the signal transfer terminals, and thuscollects data from each of the sensors. As shown in FIG. 4, the DED maycomprise mechanical interface(s) 6 for attaching the DED to terminals 4located on the sock (or another sensing device); a housing component 7protecting internal DED components and providing signal transfer fromthe sensing device (e.g., terminals on the sock) to internal DEDcomponents; electronic and communications components 10 and conductiveterminals 9 receiving signals from terminals 4 in the sock sensingdevice; a mating ring 12, and an external housing lid 13 having a powerbutton 14 for activating the DED. An alternative, simplified DED isshown in FIG. 5, comprising mechanical interface(s) 6 for attaching theDED to terminals 4 located on the sock (or another sensing device); anintegrated component 15 providing a housing, electronic andcommunications components, and an external housing lid 13. It will beappreciated that many other types and styles of DEDs may be provided forinterfacing with and downloading signals and/or data from the underlyingsock sensing device.

In one embodiment, mechanically mating snaps are used as terminalinterfaces and operated as mechanical switches that are switched on andoff abruptly by an external driving force from one switch position(attached) to a second position (detached). In another embodiment,conductive, magnetic snap switches are used as mating terminals fortransferring signals and/or data from the sock to the DED. FIGS. 12A and12B show one specific design of such snaps: an external magnetic ringmay be used on the male (DED) snap to attract and maintain solidconnection with a magnetic component of a female portion of the snaplocated on the underlying substrate. In this exemplary embodiment,properties of the magnetic field may be used to create snaps that canonly connect in one orientation: in this way, the user is guided toproperly connect the DED to the sensor system(s) associated with theunderlying substrate. Circuitry in the DED may provide the ability toautomatically turn the data collection on and off, for example, based onthe presence of the magnetic connection between the DED and the sensorsystem. It will be appreciated that many other types of mechanical andnon-mechanical interfaces may be used to attach and detach the DED fromthe signal transfer terminals, and to transfer signals and/or data fromthe sensing system to the DED.

Circuitry in the DED may be provided for reading the sensor signals;firmware may be provided for processing signal data, applying postprocessing algorithms and formatting the data for communication to anexternal computing and/or display device. The DED may incorporatefirmware and/or software components for collecting, filtering,processing, analyzing data, or the like. In one embodiment, the DEDhosts firmware subroutines that apply at least some of the following:low pass filtering algorithms to reduce incoming signal noise; pull upresistors logic to avoid shorting of the device and additional noisefiltering.

In one embodiment, the DED may be physically attached to the sensingsubstrate (e.g., sock) for data collection and then detached from thesensor terminals and physically mounted (e.g., though a USB or anotherwired connection), to an external computing and/or display device suchas a phone, personal computing device, computer, or the like to downloaddata. In other embodiments, the DED preferably has wirelesscommunication capability (e.g., using Bluetooth, WiFi, or anotherwireless standard) and transmits signals and/or data to a computingand/or display device wirelessly. The DED is thus connected through acommunication system to an external electronic device having computingand/or display capabilities. The external computing and/or displaydevice generally hosts client firmware and/or software and processingfirmware and/or software for processing, analyzing, communicating and/ordisplaying data. It will be appreciated that the division of functionsand processing, such as data processing, analysis, communications anddisplay functions as between the DED and the external computing and/ordisplay device may vary depending on many factors and is, to at leastsome extent, discretionary.

In some embodiments, client software and communications systems arehosted on the external computing device (e.g., a computer or a mobiledevice such as a tablet or smartphone), and provide feedback to andinteract with the user, communicating through an Internet connection viaweb services, to push collected data and retrieve processed data fromthe service and display (or otherwise communicate) it to the user. Theclient software may comprise a set of applications that can run onmultiple platforms (not limited to personal computers, tablets,smartphones) and sub-components (diagnostics, troubleshooting, datacollecting, snap and match, shopping) to deliver a rich and completeuser experience. The experience can be also delivered through anInternet browser.

For some applications, server software components that applycrowdsourcing logic and/or machine learning technologies may beimplemented to identify, profile, and cluster user data. The data may bestored in a database and may be continuously or intermittently updatedwith incoming user supplied and/or sensor supplied data. An optionalsoftware component that provides image and pattern recognitioncapabilities may also be implemented. This feature may allow a user toinput data (e.g. images, external data accessed from databases, etc.)without entering any text input.

While this specific example of sensor systems has been described withreference to a sock form factor, it will be appreciated that e-textilefabric sensors may be used with (and/or applied to) other types ofwearable garments (e.g., underwear, t-shirts, trousers, tights,leggings, hats, gloves, bands, and the like), and dedicated electronicdevices having different configurations may be designed to interfacewith a variety of sensor systems embodied in different types ofgarments. The type of sensor(s), garment(s), placement of sensor(s),user identification, and the like, may be input during an authenticationand initial device calibration set up protocol. Another exemplaryembodiment of a sensor system using e-textile fabric sensors in a sockform factor is shown in FIGS. 6A-13. FIG. 6A shows an exemplary fabricsensor S with leads L1 and L2. In this example, sensor S1 comprises arectangular piece of e-textile conductive fabric, and conductive leadsL1 and L2 are positioned on opposite sides of sensor S1. Conductiveleads L1 and L2 are shown as integral extensions, or pieces, of the sameconductive fabric of sensor S1, but alternative types of leads may alsobe used. FIG. 6B shows a similar fabric sensor S2 having integral leadsL3, L4 extending from a common side of the sensor. It will beappreciated that although rectangular sensors are illustrated, fabricsensors having a variety of sizes and configurations may be provided.Conductive leads having the same properties as the sensors may be used,or other types of conductive leads may be employed. It will also beappreciated that the arrangement of leads with respect to sensor(s) mayvary, depending on the properties, size and configuration of the sensorand lead components.

E-textile fabric sensors are mounted to, or associated with, theunderlying fabric substrate (e.g., a stretchable, knit fabric) in avariety of ways, including sewing, adhesive bonding, thermal bonding,and the like. FIG. 7 shows an e-textile fabric sensor S1 having theconfiguration shown in FIG. 6A attached to the inside of a stretchable,knit sock. Sensor leads L1 and L2 are sewn or bonded to the underlyingsock, and conductive traces T1 and T2 are mounted and electricallyconnected to leads L1 and L2, as shown. In this embodiment, conductivetraces T1 and T2 are fabricated from e-textile fabric materials havingdifferent properties from the materials of the sensor S1 and leads L1and L2.

The conductive traces T1, T2 terminate in conductive terminals CT1, CT2,as shown in FIGS. 8-10. In the embodiment illustrated, conductiveterminals CT1, CT2 are provided as conductive mechanical snaps,illustrated in FIG. 8, that penetrate the substrate sock material fromthe interior to the exterior surface of the sock. The interior of thesock having the sensor/lead/trace/terminal arrangement is illustrated inFIG. 9. Multiple fabric sensors may be implemented, resulting inmultiple conductive terminals communicating data collected from multiplesensors located in different areas of the foot. It will be appreciatedthat other types of sensors may be integrated in this sock formatsensing device (and in other formats of sensing devices), and thatadditional conductive terminals may be provided for transmission ofsignals and/or data from other types of sensors. The exterior of thesock having signal transfer terminals CT1, CT2 corresponding to a firstsensor, and signal transfer terminals CT3 and CT4 corresponding to asecond sensor, is illustrated in FIG. 10. In this embodiment, the signaltransfer terminals are aligned along a upper circumference of the sock,shown in this embodiment as an anklet.

One embodiment of a signal transfer and signal receipt terminalconfiguration that detachably mates, mechanically and magnetically, isshown in FIGS. 12A and 12B. This is a mechanical two-part snap devicehaving mating male (FIG. 12A) and female (FIG. 12B) connectorcomponents, as shown. The male connector 20 comprises a centralconductive pin element 21 surrounded by a non-conductive ring member 22and having a magnetic perimeter portion 23. The female connector 25comprises a central conductive pin receiving element 26 and contact thatis electrically connected to the conductive area of the male connectorwhen the connector portions are mechanically and/or magneticallyconnected to one another. Female connector 25 also comprises anon-conductive collar 27 and a magnetic collar 28 sized and configuredto mate with corresponding components of the male connector. Thecomponents illustrated in FIGS. 12A and 12B are shown in an explodedview; when assembled, the connector components nest to provide compact,highly functional connectors. The polarity of magnetic components 23, 28may be arranged to provide male and female connectors that areconnectable only when magnetically aligned in a predeterminedorientation, which may facilitate user connection of the matingterminals. Although this exemplary mating terminal configuration isillustrated having a round configuration, it will be appreciated thatother configurations, including oval, linear, polygonal, and the like,may be used.

FIGS. 11A and 11B illustrate one exemplary embodiment of a dedicatedelectronic device (DED) 40 having signal receipt terminals RT1, RT2,RT3, RT4 that mate mechanically with conductive terminals such asCT1-CT4 to provide signal and/or data transfer from thesensor/lead/traces associated with the sock substrate to the DED. DED40, as illustrated in FIGS. 11A and 11B, comprises a curved housing orcase enclosing an interior space containing processing, memory and/orcommunications components. In this embodiment, DED 40 may be installedon the exterior of a sock in the ankle or lower leg area of the user, asillustrated in FIG. 13. DED 40 preferably provides a protective andwatertight housing or case protecting the electronic components providedwithin the housing. The housing may be provided as a substantially rigidor a substantially flexible component and a variety of DED form factorsmay be provided, depending on the type and arrangement of underlyingsubstrate and signal transfer terminals.

The DED incorporates processing, memory and/or communicationsfunctionalities within the housing. A schematic diagram illustratingexemplary DED components and interfaces is shown in FIG. 14. The DED hassignal receipt terminals (shown as “snap connectors”) that feed analoginput signals to appropriate processing means, such as analog filters,A/D converters, and to a processing component. Optional manual controlinput(s) and one or more optional output display(s) may be provided inor on the DED, as shown. Local memory may also be provided, and meansfor communicating signals and/or data externally via wired or wirelessprotocols may be provided, as shown. Signals and/or data is communicatedfrom the DED to an external computing facility or device, such as acomputer, base station, smartphone, or another bridge device, and/or toa centralized, hosted facility in a remote location, such as in theCloud or at a centralized data processing and analysis facility.Following data analysis in accordance with predetermined and/orpre-programmed instructions, data output, analysis, notifications,alerts, and the like are communicated from the centralized hostedfacility to the bridge device, and/or the DED, as shown. It will beappreciated that this is one exemplary data flow scheme, and that manyother work flows may be advantageously used in connection with sensingsystems of the present invention.

Although these specific embodiments have been illustrated and describedwith reference to the wearable substrate having a sock form factor, itwill be appreciated that the sensors, leads, traces and terminals, aswell as different types of DEDs may be adapted for use in other types ofgarment and non-garment applications. Similar types of flexiblee-textile sensors may be applied to or associated with a wide variety ofnon-conductive underlying flexible substrate materials, including wovenand non-woven materials, and incorporated in a variety of sensorsystems. Additional exemplary systems are described below, and arenon-limiting.

Wrap, Band and Sheet Sensor Applications

In additional applications, flexible sensors and sensor systems of thepresent invention may be fabricated as independently positionable sensorcomponents and used in a variety of applications. FIG. 15 schematicallyillustrates an independently positionable sensor system compnsmg aflexible pressure sensor S1 electrically connected, via leads (notvisible), to conductive traces T1 and T2, which are in turn electricallyconnected to conductive signal transfer terminals CT1 and CT2. Thepressure sensor S1, leads, and/or conductive traces may be mounted to orassociated with an underlying non-conductive flexible substrate toprovide mechanical integrity to and enhance the durability of thesystem. It will be appreciated that this type of independent flexiblesensor system may be fabricated using a wide variety of sensor sizes,and sensor functions, trace lengths, configurations, underlyingsubstrates, and the like, and that additional and different types ofsensors may be incorporated in such independent flexible sensor systems,as described above.

One or more of these types of independently positionable flexible sensorsystems may be positioned by a user, caretaker and/or clinician at adesired body site and anchored at the site using bands, wraps, or otheranchoring devices. FIGS. 16A and 16B schematically illustrate the use ofan independently positionable sensor system on the surface of or withina bandage wrapped around a foot. FIG. 16A shows the sensor S1 positionedas desired at a location near the bottom of the foot. The sensor S1 maybe anchored to the desired sensing location, if desired, using a varietyof non-conductive anchoring means such as hook and loop and other typesof fasteners. Fastening means, such as hook and loop fasteners, may bemounted on or associated with a surface (or partial surface) of thesensor S1. The conductive traces T1, T2 transmit signals/data toconductive signal transfer terminals CT1, CT2 positioned or positionableat an accessible external location, such as at the top of the foot or atan ankle or lower leg position, as shown in FIG. 16B, providing accessfor connection of a DED and data downloading. Wraps, bands, bandages, orother anchoring systems may be wrapped around the sensor systemfollowing placement to secure the sensor system, and sensor, in place atthe desired sensing location and to maintain external access to thesignal transfer terminals.

FIG. 17 illustrates a foot wrap 50 having an integrated sensor system,or employable in combination with an independently positionable sensorsystem such as that illustrated in FIGS. 16A and 16B positioned insidethe wrap 50, between the interior surface of wrap 50 and the foot (oranother body surface). The sensor is located at a desired sensing siteon the foot and the conductive signal transfer terminals CT1, CT2 arepositioned outside wrap 30 at a location that is accessible to a DED. Itwill be appreciated that while this type of wrap system is shown anddescribed with reference to a foot wrap, it may be embodied in varioustypes of wraps, bandages, wound and/or ulcer dressing materials and thelike having a variety of sizes, configurations, and sensingcapabilities. The location of the sensor(s) and conductive signaltransfer terminals, and the path of the conductive traces, is highlyflexible and may be adapted for sensing in many different types ofapplications.

FIGS. 18A and 18B illustrate one exemplary embodiment in which one ormore protective layers or materials may be provided to protect one ormore sensor(s) and, optionally the associated leads, and all or portionsof conductive traces, from contact with liquids, body fluids or othersolutions, while preserving the core resistive features and functions ofthe sensor(s). A protective barrier may comprise a liquid impervious orsubstantially liquid impervious material, such as a generally thinplastic sheet material or a composite sheet material, that doesn'tinterfere with the sensing capacity of the sensor. By “substantially”liquid impervious we mean that liquid penetration of the material isinsubstantial enough to affect the features and functions of thesensor(s). The protective barrier may optionally be breathable and/orgas permeable. Many such liquid impervious barrier materials are known.In some embodiments, a protective barrier may be provided on one surfaceof the sensor; in some embodiments, a sandwich- or envelope-type barrierthat substantially seals the sensor in a substantially liquidimpermeable envelope or pouch may be used.

In the embodiment shown in FIGS. 18A and 18B, barrier 30 comprises athin, flexible sheet material and extends over and around sensor S,enclosing the sensor in a liquid impervious barrier or envelope. In theembodiment shown, surfaces or edges of barrier 30 are sealed, forming apouch around the perimeter of sensor S at seal 31. An adhesive band 32may be provided on one face (or both faces) of the protective barrierfor mounting the sealed sensor component to an underlying surface orsubstrate (such as a garment, the skin of the user, or the like).Although adhesive band 32 is shown forming a peripheral band outsideseal 31, it will be appreciated that adhesive components, as well asother types of mounting mechanisms, may be applied to or used inconnection with protected sensor components. In the embodiments shown inFIGS. 18A and 18B, sensor S and leads L1 and L2 are encased withinprotective barrier 30; conductive traces T1 and T2 exit barrier 30 forattachment to conductive signal transfer terminals (not shown).Additional material layers may be provided inside and/or outside thebarrier as shown in FIG. 18B to provide any desired functionality.

FIG. 19 schematically illustrates flexible pressure sensors S havingconductive leads L1, L2 electrically connected to conductive traces T1,T2 in place on a flexible bandage 35 or on a wrap or another substratefor placement on or near wounds. The signal transfer terminals (notshown) are located on opposite sides of the bandages and may beconnected to independently positionable signal receiving terminals forsignal transfer. This system provides flexibility as to placement of thebandages having different sizes and configurations on different bodysurfaces and on body surfaces of different sizes and configurations,while permitting convenient and flexible signal transfer.

FIG. 20 schematically illustrates a plurality of pressure sensors(S1-S6) mounted to/in/on, or associated with, a substrate sheet material36 that's flexible and non-conductive. Each of the sensors S1-S6 hasconductive leads electrically connected to conductive traces thatterminate in signal transfer terminals located at the edge of thesubstrate 36. The signal transfer terminals are connectible to matingsignal receiving terminals of one or more DED(s), also mountable at theedge of the substrate. In this embodiment, the DED may have a strip-likeform factor for connecting to aligned signal transfer terminals. Thistype of sensor arrangement and system may be used, for example, inconnection with various types of garments, bed sheets, chair pads, orthe like, to provide data regarding pressure and/or shear at locationswhere a user sits, lies, or the like.

FIG. 21 schematically illustrates exemplary computer- and/or firmware-and/or software-implemented processes used by a medical monitoringsystem of the present invention. In some embodiments, patient setup and(optional) device authentication, program selection and the like areprovided, as well as a user and/or clinician dashboard providing dataoutput and analysis in accordance with the program selection. Onespecific example of output returned to the user and/or clinician isillustrated as patient offloading data, expressed as excess pressure,which provides information to the user and/or clinician as to pressureconditions (and conditions of the underlying skin and tissue) at thesite of any of the pressure sensors provided in the system.

In one exemplary methodology of the present invention, a garment havingone or more sensing systems as described herein is positioned on a userwith sensor(s) positioned in proximity to a body area desired to bemonitored, or an independently positionable sensing band, or bandage, orsubstrate is positioned relative to one or more body surface areas of auser desired to be monitored. A dedicated electronic device is mountedto/on or associated with exposed signal transfer terminals of thesensing system and an authentication protocol is initiated to match thegarment/sensing system to the user. The authentication protocoloptionally loads user data, profile information, and the like, to one ormore hosted systems, such as a centralized data processing and analysisfacility, a medical records facility, a caretaker system, cliniciandashboard, or the like. Sensor calibration may then be conducted basedon user specific information, conditions, and the like, and thresholds,limits or specific ranges, monitoring protocols, notifications, alerts,and the like may be selected by the user, a caretaker, clinician, or bythe system to apply user-specific monitoring routines, parameters, andthe like. Intermittent or substantially continuous user monitoring maythen be initiated, with monitoring data and results provided to theuser, a centralized data processing and analysis facility, a medicalrecords facility, a caretaker system, clinician dashboard, and the like.Changes and updates to monitoring protocols may be implemented based onmonitoring feedback, changes in user condition, etc.

FIGS. 22A-22L schematically illustrate exemplary device set up,calibration and monitoring criteria input, along with an exemplaryclinician dashboard, a graphical representation of patient offloadingdata, and an exemplary sample of acquired pressure data. Processingsystems and means for executing device set up and calibration, and formonitoring and reporting sensed data may reside at a computing facilitythat is remote from the sensing device or means and the dedicatedelectronic device and may comprise computer implemented systems andmethods at a host computer system, a medical facility computer system,in a computing environment such as the Cloud, or the like. Reports maybe displayed at the computing facility, or at any display device (e.g. amonitor, smartphone, computer, electronic healthcare system, or thelike) that is capable of communicating with the computing facility.

FIG. 22A schematically illustrates an exemplary setup and calibrationprotocol involving a patient information setup routine, a deviceinformation set up routine, a monitoring criteria set up routine and acalibration routine. A variety of different routines are available forpatients having different conditions, for different deviceconfigurations, sensor types and locations, monitoring protocols, andthe like. Various routines may be programmed or programmable andselectable by a user and/or by medical personnel. The routines mayreside in the DED, a computing device or another bridge device, in cloudservices, or the like.

FIG. 22B schematically illustrates an exemplary patient data collectionprotocol forming part of the patient information setup. In this example,a doctor or another medical professional can collect and input data toassociate to the specific patient/device pair. Patient identification,patient-specific information like weight, height, condition, physician,ulcer location and condition, as well as procedures undergone, hospitaladmissions, notes, and the like not only add information related to thespecific case, but can also be used as guidance for the devicecalibration procedure. This information also provides meaningful data touse in aggregated views of the overall patient data.

FIGS. 22C-22F schematically illustrate exemplary device setup protocolsincluding a sensor activation selection menu. In this exemplary devicesetup routine, the system model number and identification is provided,along with the type of data collection. Real-time alerting andnotification features may be selected. Various sensors and sensorlocations may be selected and activated, while others may remaininactivated, as shown in FIGS. 22C and 22D. FIG. 22D illustrates anexemplary sensor activation menu for a sock type sensor surface, wherethe doctor or medical assistant can activate specific sensors in a setof 5 available for the specific example.

FIG. 22E illustrates an exemplary sensor activation menu for adressing/wrap type sensor surface, where the doctor or medical assistantcan specify which type of sensor (A, B, C in the specific example) willbe used for any specific patient. FIG. 22F illustrates an exemplarysensor activation menu for an insole type sensor surface, where thedoctor or medical assistant can activate specific sensors in a set of 5available for the specific example.

FIG. 22G schematically illustrates monitoring criteria selection menus,including a monitoring threshold selection menu and a notificationselection and activation menu. FIG. 22H schematically illustrates inmore detail the monitor thresholds and notification selection andactivation menu. In this example, the doctor or medical assistant candefine different thresholds to monitor before and after the first 72hours post medical procedure or post sensor activation.

The exemplary monitor thresholds define two levels of severity: yellowand red. In one embodiment, the yellow threshold can be surpassed for alimited period of time (for example 5 minutes every hour) withoutconsequence: after this time-based threshold has been surpassed, thesystem will alert the patient or caregiver according to a notificationor alert protocol. This embodiment also allows the use and selection ofa red threshold that, if it is surpassed at any time, the system alertsthe patient or caregiver immediately. Thresholds are managed through ahysteresis cycle, to avoid multiple alerts to be raised when thepressure level is averaging around the threshold level. The thresholdlevels can be preset by the parameters input for the patient and basedon historical data, or defined/tuned by the doctor or medical assistant.Notifications may include vibration of the device, e-mails sent tospecific addresses, text messages sent to specific phone numbers,robo-calls from an automated speech system, or the like, and thenotification type, frequency, etc. may be set by the user or a medicalprofessional as part of the monitoring routine, as shown. In someembodiments, daily reports may be sent to the doctor or caregiver foreach patient using such a sensor system.

FIG. 22I schematically illustrates a sample calibration protocol forautomatic set up of parameters such as filter thresholds, signal gain,voltage-to-pressure formulae, and the like, based on user-specificcriteria. In this calibration, background data may be collected whilethe user is in various positions or doing various activities, such assitting, standing, walking, or the like, to collect patient-specificdata so that various parameters of the sensing system may be normalizedto, or standardized against patient-specific “normal” parameters.

FIG. 22J illustrates an exemplary clinician dashboard displayingdiabetic patient data by patient name, medical condition, foot ulcerlocation and condition, medical procedural history, monitoring sensordevice and location, substantial real-time monitoring information, andpatient status based on monitoring information. In the cliniciandashboard shown, patients are categorized in red, yellow or green statusbased on monitoring information so that clinicians may contact and checkon patients having conditions categorized in the red status and avertmore serious conditions. The doctor or medical assistant can pivot thedata on different “dimensions”, such as type of offloading device,medical condition, ulcer location, etc. The doctor or medical assistantcan also filter and sort data based on the same dimensions, to extract aview of the data aggregated for specific area of interest, both for easeof access as well as statistical purpose. For example, by analyzing thisdata as aggregate, specific types of offloading devices, coupled withspecific types of monitoring devices used, might show a better outcomefor patients with ulcers in the metatarsal area.

FIG. 22K schematically illustrates a patient offloading data displayclearly showing excessive pressure exerted at sensing locations inreal-time and historically, and providing a history of notifications andalerts provided. This data can be used by the doctor or medicalassistant for the purpose of analyzing in detail the behavior of apatient, observing correlations and outcomes, as well as to provide thebasis for honest conversations with patients about their behavior andhow it affects the healing process. The same data can also be used tosend reports to the patient, with emphasis on the good habits andpositive reinforcement to improve the adherence and help the healingprocess.

FIG. 22L schematically illustrates sensed force/pressure data collectedusing a sensing system as described herein with sensors located at theheelbone and at a metatarsal area, with signals in areas A and Billustrating data collected while the user walked 10 steps; signals inarea C corresponding to the user jumping, signals in area Dcorresponding to the user shifting his weight, and signals in areas Eand F illustrating data collected while the user walks additional stepsfollowing the previous activity. It will be appreciated that many othertypes of input and output may be provided in connection with sensorsystems of the present invention, and that these diagrams are providedfor purposes of illustrating specific examples of useful input andoutput and do not limit the invention in any way.

Medical and Athletic Monitoring

The specific examples of sensors and sensor systems described herein areapplicable to patients with multiple types of foot related problems suchas flat foot, injuries from accidents or military personnel injured onthe battle field or patients suffering from peripheral neuropathy, andmore specifically diabetic neuropathic feet wherein portions of the footmay be insensitive to pressure. The user, caretaker and/or clinician maybe alerted to lack of patient adherence to offloading guidance, areas ofexcess pressure and/or shear, substantially in real-time, to facilitateprevention of ulcer formation and to promote ulcer and wound healing.

In one scenario, a user/patient or an athlete wears a sock incorporatinga flexible sensing system, as described. They turn on the device using aswitch on the DED and put the foot in a shoe. The DED establishes aconnection with one or more remote computing devices or services (e.g.,via USB/Wi-Fi/Bluetooth/other medium), and pressure-related data istransferred to the remote computing device/service, where dataprocessing and analysis takes place. Ranked recommendations related topatient adherence, performance and goal achievements, injurypreventions, what/if analysis may be communicated and displayed to thepatient, athlete and/or coach/caregiver in substantially real-time,allowing the patient, athlete and/or coach/caregiver to make changes tothe patient's or athlete's behavior or activity in response to thesensed pressure and returned results.

In another embodiment, systems incorporating the DED and signal receiptterminals may be mounted to and/or incorporated in or associated withother types of intermediate dedicated electronic devices, such as aprotective device (e.g., a shin guard). One version of this embodimentis illustrated in FIG. 23. In this embodiment, a substrate material inthe form of a sock may be equipped with one or more sensors S1 . . . Sn,leads and traces T1 . . . Tn that provide signals and/or data to a setof terminals CT1 . . . CTn. The terminals may comprise snaps, orconnectors, mounted on the sock (male or female part) and on matinglocations on a protective device, such as a shin guard device (female ormale counterpart). The connectors on the sock may be located in areaswhere the shin guard usually overlies the sock, such that thecounterpart connectors on the shin guard easily snap together andconnect not only the terminals, but the sock and the shin guard. Theshin guard can be manually positioned between the sock and the shin ofthe wearer, of be inserted in a proper fabric socket built-in the sock.In this embodiment, the shin guard is generally fabricated from a harderouter casing material and a shock absorber material on the inside.Electronic components of the dedicated electronic device (DED), asdescribed earlier, may be provided in a core area or recess within theshin guard, well protected from excessive impact. The DED gathers datafrom each sensor by means of direct connections between itsinputs/outputs and mating terminals CT1 . . . CTn and communicatessignals and/or data to an external computing and/or bridge device, asdescribed previously.

This type of arrangement may be used in a variety of sports that requireleg and/or foot protection (e.g. soccer, hockey, football, etc.).Sensors may be placed in specific locations on a sock or another item ofapparel, dependent on the type of sport and activity that is desired tobe monitored. In one scenario, a soccer team may wear a sensor equipped(instrumented) sock and the shin guard with embedded DED to collectpressure data that can be processed in real-time or after the fact andextract useful statistical data for the individual and the team. Forexample, by placing specific sensors on the sides of the sock (foot), asoftware system receiving the data from the DED may be capable ofdetermining whether the pressure signal spikes coming from the innersensor are related to run, walk, a pass or a shot. The system mayprovide statistical data such as number of passes, number of shots, ballpossession, etc. by means of data analysis and synthesis.

Footwear Fitting

Throughout the footwear industry, there are multiple internationalsizing systems and, even more importantly, a lack of standardization inshoe sizing. Sensors and sensing systems of the present invention mayalso be used to assist in footwear fitting. When consumers buy or orderfootwear in a store or online, it's difficult to assess proper fit,particularly given the large selections available and without theability to try on footwear in their specific everyday scenario. Evenwhen consumers shop in a store and have the ability to try footwear on,the location and the limited time and experience may not identify poorlyfitting footwear. This results in lost sales opportunities and highreturn rates, which discourages consumers from making online purchasesand significantly raises sales costs for online merchants. Being able topurchase and order footwear having confidence that it will fit wellwould provide substantial benefit. In 2010 three hundred and fiftymillion shoes were sold online, however about a third got returned. Ecommerce has seen tremendous growth in recent years; however, onlinefootwear sales make up only 12% of the total footwear market (comparedto 50% for computers and 60% for books). The reason is that consumersare less comfortable buying shoes online since they cannot try onfootwear before purchasing.

Pressure sensor(s) incorporated in a sock form factor, or positioned asindependently positionable sensors, may be used to detect pressure ondifferent points and areas of the foot and identify areas of discomfort.Using databases and data analysis of pressure sensors positioned on auser's foot, analytics may find and display recommended fit options forshoes, insoles and/or orthotics for specific individuals, and theindividual may be alerted in real-time as to recommended fit options.The device-collected sensor data can be augmented with individualizedinformation provided directly by the user(s), such as requested shoetype, model, or other search criteria.

In another embodiment, pressure sensors incorporated in a sock formfactor, or in independently positionable sensing systems, may collectcomfort and anatomic data as well as data relating to humidity,temperature, and other parameters at one or more locations on anindividual's foot. The collected data may be augmented with userprovided information, such as requested shoe type, model, and othersearch criteria, which may be processed to provide output asindividual-specific recommendations and alerts.

In another embodiment, a user may take a picture of a shoe and send theimage to a computing device or service (e.g. via e-mail). The footwearimage may be processed and matched to footwear metadata maintained inone or more database(s) to identify potential matching footwear. Aselection of related shoes, including the matching one, may be presentedto the user. The selection may take in account comfort zones and footanatomy of the current user that share common features and needs, andmay rank the returned selection according to various parameters or userpreferences. In one embodiment, the DED control software collects datafrom a sensor system to determine the anatomy of the foot. Once wearer'sanatomical foot data is processed and compared to footwear datamaintained in one or more databases, footwear recommendations may bedisplayed to the wearer, ranked according to projected fit, or otheruser preference(s). These systems, or similar systems, may be used tofind and display ranked recommended fit options for footwear, insolesand/or orthotics.

While the present invention has been described above with reference tothe accompanying drawings in which particular embodiments are shown andexplained, it is to be understood that persons skilled in the art maymodify the embodiments described herein without departing from thespirit and broad scope of the invention. Accordingly, the descriptionsprovided above are considered as being illustrative and exemplary ofspecific structures, aspects and features within the broad scope of thepresent invention and not as limiting the scope of the invention.

1. A sensing device comprising: at least one piezoresistive fabric sensor; at least two electrically conductive leads extending from each piezoresistive fabric sensor; at least one electrically conductive trace connected to each conductive lead; and at least one signal transfer terminal electrically connected to each conductive trace; wherein each trace is fabricated from a Material having different properties from the piezoresistive fabric sensor and lead material, and at least one piezoresistive fabric sensor, at least two electrically conductive leads, at least one electrically conductive trace, and at least one signal transfer terminal is associated with a non electrically conductive substrate that is flexible and stretchable.
 2. The sensing device of claim 1, additionally comprising at least one additional non-fabric sensor.
 3. The sensing device of claim 1, wherein the at least one piezoresistive fabric sensor is capable of sensing pressure or force exerted on the sensor.
 4. The sensing device of claim 1, wherein the at least two electrically conductive fabric leads extending from the at least one piezoresistive fabric sensor and are formed as integral extensions of the at least one piezoresistive fabric sensor.
 5. The sensing device of claim 1, wherein the at least two electrically conductive leads are positioned on opposite sides of the at least one piezoresistive fabric sensor.
 6. The sensing device of claim 1, wherein the non-electrically conductive substrate is in the form factor of an insole, shoe, boot, belt or strap.
 7. The sensing device of claim 1, wherein the non-electrically conductive substrate is in the form factor of a wearable garment.
 8. The sensing device of claim 7, wherein the non-electrically conductive substrate is in the form factor of a sock or an anklet.
 9. The sensing device of claim 7, wherein the wearable garment is selected from the group consisting of: shirts, underwear, leggings, footies, gloves, caps, body bands and brassieres.
 10. The sensing device of claim 1, wherein the non-electrically conductive substrate is in the form of a bandage, wrap, band, wound dressing, sheet or pad.
 11. The sensing device of claim 1, additionally comprising at least one sensor capable of sensing at least one of moisture and temperature.
 12. The sensing device of claim 1, additionally comprising a dedicated electronic device having signal receipt terminals that mate with signal transfer terminals of the sensing device and a housing component with signal processing and communications components located within the housing component.
 13. The sensing device of claim 12, wherein the housing component is flexible.
 14. The sensing device of claim 12, wherein the housing component of the dedicated electronic device is in the form of a curved housing configured to fit partially around the front portion of a user's lower leg or ankle.
 15. The sensing device of claim 12, wherein the signal receipt terminals of the dedicated electronic device and the signal transfer terminals of the sensing device are mounted in cooperating fixtures for sliding engagement of terminals.
 16. The sensing device of claim 12, wherein the signal receipt terminals of the dedicated electronic device and the signal transfer terminals of the sensing device are configured for magnetic engagement of terminals.
 17. The sensing device of claim 12, additionally comprising an accelerometer.
 18. A sock comprising at least two piezoresistive sensors; at least two electrically conductive leads extending from each piezoresistive sensor: at least one electrically conductive trace connected to each of the conductive leads: and at least one signal transfer terminal electrically connected to each of the conductive traces; wherein the signal transfer terminals are arranged in proximity to one another in a location corresponding to a front portion of a users lower leg or ankle region.
 19. The sock of claim 18, in combination with a dedicated electronic device having signal receipt terminals that mate with signal transfer terminals of the sock and a flexible housing component in the form of a curved housing configured to fit partially around the front portion of a user's lower leg or ankle, with signal processing and communications components located within the housing component.
 20. A system for data collection and remote monitoring of conditions at or near a body surface, comprising: at least one sensing device configured for positioning in direct or indirect contact with a portion of a user's body surface and having signal transfer terminals associated with a flexible, non-conductive substrate; a dedicated electronic device having signal processing and communications components and signal receipt terminals that receive signals from the signal transfer terminals of the sensing device; and a remote computing facility configured to receive data from the dedicated electronic device and execute data analysis in accordance with at least one of programmed and programmable instructions and routines, wherein the at least one sensing device comprises at least one piezoresistive fabric sensor; at least two fabric leads extending from each piezoresistive fabric sensor; and at least one electrically conductive trace connected to each conductive lead and terminating in one of the signal transfer terminals.
 21. A method for fitting footwear to a users feet, comprising: placing at least one pressure sensor of a sensing device comprising a flexible, piezoresistive sensor, at least two flexible leads connected to the sensor, at least one flexible, electrically conductive trace connected to each of the leads, and at least one signal transfer terminal electrically connected to each of the flexible, conductive traces at a location at or near an area of the user's foot; placing footwear on the user's foot and thereby locating the at least one pressure sensor between the user's foot and the footwear; collecting data relating to sensed pressure conditions while the user wears the footwear; augmenting collected data with user information; and providing user-specific recommendations for footwear that fits the anatomy of the user's foot.
 22. The method of claim 21, wherein the at least one pressure sensor is incorporated in a sock form factor. 